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505 - Dear PAAB - would a branded APS comprised of only a provincial listing (with clinical criteria/notes), require high-level balance or low-level balance? Note this assumes that all listing criteria is on-label.

Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists

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Jennifer Carroll

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Lowest provided the criteria does not include a claim which triggers highest level (e.g. efficacy/safety claim) or middle (e.g. pharmacokinetic claim).
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